QNASL- beclomethasone dipropionate aerosol, metered QNASL- beclomethasone dipropionate aerosol, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BECLOMETHASONE DIPROPIONATE (UNII: 5B307S63B2) (BECLOMETHASONE - UNII:KGZ1SLC28Z)

Available from:

Teva Respiratory, LLC

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

QNASL® Nasal Aerosol is indicated for the treatment of the nasal symptoms associated with seasonal and perennial allergic rhinitis in patients 4 years of age and older. QNASL Nasal Aerosol is contraindicated in patients with a history of hypersensitivity to beclomethasone dipropionate and/or any other QNASL Nasal Aerosol ingredients [see Warnings and Precautions (5.3)] .  Risk Summary There are no adequate and well-controlled studies with QNASL Nasal Aerosol or beclomethasone dipropionate in pregnant women. No published studies, including studies of large birth registries, have to date related the use of inhaled corticosteroids (ICS) or intranasal corticosteroids to any increases in congenital malformations or other adverse perinatal outcomes.  Thus, available human data do not establish the presence or absence of drug‑associated risk to the fetus.  In animal reproduction studies, beclomethasone dipropionate resulted in adverse developmental effects in mice and rabbits at subcutaneous doses equal to or great

Product summary:

QNASL Nasal Aerosol is supplied in 2 strengths and supplied as a pressurized aluminum canister inserted into a blue and white plastic nasal actuator with a built-in dose counter and white dust cap, as follows: QNASL 80 mcg Nasal Aerosol contains 10.6 g of drug and excipients and provides 120 actuations (NDC 59310-410-12).  Each actuation delivers 80 mcg of beclomethasone dipropionate from the nasal actuator and 100 mcg from the valve. QNASL 40 mcg Nasal Aerosol contains 6.8 g of drug and excipients and provides 60 actuations (NDC 59310-406-06).  Each actuation delivers 40 mcg of beclomethasone dipropionate from the nasal actuator and 50 mcg from the valve. Each canister of QNASL Nasal Aerosol has a dose counter, which initially reads 60 sprays or 120 sprays for the respective products, and counts down each time a spray is released.  The correct amount of medication in each intranasal dose cannot be ensured after the counter reads 0; therefore, the device should be discarded when the counter reads 0. Do not remove the QNASL Nasal Aerosol canister from the actuator.  The QNASL Nasal Aerosol canister should only be used with the QNASL Nasal Aerosol actuator and the actuator should not be used with any other drug product. CONTENTS UNDER PRESSURE Do not puncture.  Do not store near heat or open flame.  Do not expose to temperatures higher than 49°C (120°F) as this may cause bursting of the canister.  Never throw the device into a fire or an incinerator. Store at temperature between 20° and 25°C (68° and 77°F); excursions are permitted between 15° and 30°C (59° and 86°F). Keep out of reach of children.

Authorization status:

New Drug Application

Summary of Product characteristics

QNASL- BECLOMETHASONE DIPROPIONATE AEROSOL, METERED
TEVA RESPIRATORY, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QNASL NASAL AEROSOL
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR QNASL
NASAL AEROSOL.
QNASL (BECLOMETHASONE DIPROPIONATE) NASAL AEROSOL
FOR INTRANASAL USE ONLY
INITIAL U.S. APPROVAL: 1976
INDICATIONS AND USAGE
QNASL Nasal Aerosol is a corticosteroid indicated for the treatment of
nasal symptoms associated with
seasonal and perennial allergic rhinitis in patients 4 years of age
and older. (1.1)
DOSAGE AND ADMINISTRATION
QNASL Nasal Aerosol is for intranasal use only.
The recommended dose of QNASL 80 mcg Nasal Aerosol in patients 12
years and older is 320 mcg per
day administered as 2 actuations in each nostril once daily (maximum
total daily dose of 4 actuations
per day). (2.1)
The recommended dose of QNASL 40 mcg Nasal Aerosol in children aged 4
to 11 years of age is 80
mcg per day administered as 1 actuation in each nostril once daily
(maximum total daily dose of 2
actuations per day). (2.1)
DOSAGE FORMS AND STRENGTHS
QNASL Nasal Aerosol is available in two strengths:
Each actuation of QNASL 80 mcg Nasal Aerosol delivers 80 mcg of
beclomethasone dipropionate. (3)
Each actuation of QNASL 40 mcg Nasal Aerosol delivers 40 mcg of
beclomethasone dipropionate. (3)
QNASL 80 mcg Nasal Aerosol is supplied in a 10.6 g canister containing
120 actuations; QNASL 40 mcg
Nasal Aerosol is supplied in a 6.8 g canister containing 60
actuations. (3)
CONTRAINDICATIONS
Patients with a history of hypersensitivity to beclomethasone
dipropionate and/or any other QNASL Nasal
Aerosol ingredients. (4)
WARNINGS AND PRECAUTIONS
Nasal discomfort, epistaxis, nasal ulceration, _Candida albicans_
infection, nasal septal perforation,
impaired wound healing. Monitor patients periodically for signs of
adverse effects on the nasal mucosa.
Avoid use in patients with recent nasal ulcers, nasal surgery, or
nasal trauma. (5.1)
Eye Disorders. Monitor p